and Biotechnology IGB and CinnaGen Company cloned Interferon beta‐1a and since 2006 the drug has been sold as CinnoVex®, a biosimilar, in Iran.
Indication: Multiple sclerosis (MS)
Manufacturer: Biogen Idec
Global Sales in 2017: US$2.1 billion
Generic name: Interferon beta‐1a
Launch date: 1996
2.9.10 Lucentis ®
Developed by Genentech, ranibizumab, an injectable, is marketed in the United States by Genentech and by Novartis outside the United States.
Indication: Age‐related macular degeneration
Manufacturer: Roche, Novartis
Global Sales in 2017: US$1.5 billion
Generic name: Ranibizumab
Launch date: 2006
2.10 Top 10 Biologic Drugs in the EU
The top ranked biologics in the EU are predominantly the same as in the United States.
2.11 Conclusions
The biologic market is large and rapidly expanding. It accounts for over a quarter of pharmaceutical spending, giving it increasing payer attention. The pipeline contains a growing share of biologic drugs preparing to launch into therapy areas that have seen very little biologic use historically, such as Alzheimer's, asthma, and cardiovascular diseases. Extremely large patient populations in these areas will accelerate biologic drug budget growth. Additionally, novel therapeutic technologies in the pipeline such as gene therapies and autologous cell therapies will also be launched with greater frequency. The high cost per patient for some of these potentially curative products will place immense pressure on drug budgets further.
When launching a biologic into this payer environment, pharmaceutical companies should look seriously at alternative funding mechanisms. Pay for performance schemes have successfully been implemented in the United States. However, other novel mechanisms should be explored, with different mechanisms varying in effectiveness depending on the specific treatment and regulatory jurisdiction. Examples include: differential pricing, which can be based on which indication a drug is used for or the severity of the patient condition; payment in installments, which spreads an acute one‐off budget impact into manageable portions, e.g. in indications with patient warehousing:
Larger patient populations and budget constraints favor a strategy based on volume growth. The growth of biologic manufacturing capability in the Far East has enabled the production of cheaper biologics. Companies should look at opportunities to reduce manufacturing costs with the primary ambition of expanding access, particularly in less developed markets where drug cost is more likely to limit access.
Launching a biologic into a nontraditional biologic indication creates unique challenges that must be actively overcome. For example, the majority of patients for these biologics will historically have been treated by primary care physicians, who may have had little exposure to biologics. Without appropriate education, these gatekeepers may not efficiently refer patients through to the appropriate specialists who can carry out treatment. A coordinated, multichannel approach can supplement physician education while maintaining commercial cost effectiveness.
Older products in traditional biologic therapy areas are being joined by competitors, both original and biosimilar, fragmenting the at‐present concentrated market and applying downward pricing pressure. The scale of the biosimilar pipeline will ensure that in the future, off‐patent competition will come rapidly after key patent expiry, giving originators little hope of maintaining unprotected and guaranteed biologic revenue.
Originators planning to protect a franchise from biosimilars must ensure that follow‐on biologics are a strong value proposition for payers. Players should direct the development of follow‐ons to improve efficacy, reduce side effects or effectiveness in patients not clinically satisfied with current biologics. Easier administration or patient support services are nice to have but may not make the difference between a low‐cost biosimilar and a costlier newer agent.
The on‐patent innovative biologic market will also be under greater competitive pressure. Recent launches of biologics have more quickly been followed by other originator competitors, often with the same mechanism of action. The pipeline follows this trend with more launches forecast for autoimmune indications, diabetes combinations, oncology checkpoint inhibitors, EGFR inhibitors, and respiratory biologics. In this more competitive landscape, first to market advantage will be short lived. Rapidly maximizing market share is more important than ever, and promotional strategy should reflect this. However, expectations for biologic launches should still be adjusted accordingly and pragmatically applied during business development.
Players should carefully plan the timing of a product acquisition. The stabilization of deal price in this political environment may present favorable opportunities.
Companies should look earlier in development for acquisition targets. Strong competition and relatively high prices have left fewer valuable late‐stage assets.
It will be increasingly important for companies to strengthen the competencies required to nurture a biologic pipeline candidate, particularly if they have historically been small molecule focused.
Ranging from incumbent biologic drugs to areas with no currently available biologics, the market is undergoing an unprecedented period of change. Market leadership will be at stake. As more companies bring biologics into the mainstream of their portfolio and biologics become mainstream across more and more therapies, the companies that thrive will be those that are bold in their investments, effective in their product differentiation, and innovative in their commercial model and acumen.
References
1 1 https://www.researchgate.net/publication/228730641_Biosimilars_An_overview (accessed 20 September 2019).
2 2 https://researchadvocacy.org/sites/default/files/resources/Biosimilar%20Medicines6_4Final.pdf (accessed 20 September 2019); World Health Organization. Biological Qualifier: An INN Proposal.
3 3 https://www.fda.gov/drugs/therapeutic‐biologics‐applications‐bla/biosimilars (accessed 20 September 2019).
4 4 Programme on International Nonproprietary Names (INN). Revised draft July 2014. http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf (accessed 20 September 2019).
5 5 European Medicines Agency. Product‐Information Requirements. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000199.jsp; https://www.ema.europa.eu/en/documents/leaflet/biological‐medicinal‐products_en.pdf (accessed 20 September 2019).
